Medical device recalls in 2022What FDA recall data shows

Updated Oct 18, 2026 · FDA recall data dated Oct 16, 2026

Key findings

The FDA posted 1,161 medical device recall records in 2022, from 332 recall events by 200 companies — 217% more than the same period of 2021 (366).
143 records (12%) are Class I, the most serious category (same period of 2021: 118).
The product line named in the most recall records was V. Mueller (Steris Corporation), with 45.
Baxter Healthcare Corporation had the most recall events (13, covering 31 records).
The most common FDA root-cause category was “Under Investigation by firm” (20% of records).

Recall records by month

23Jan 22Feb 15Mar 44Apr 13May 21Jun 35Jul 98Aug 117Sep 153Oct 176Nov 444Dec

Red = Class I. Click a month for every recall posted that month.

Most-recalled product lines

Product lines whose models are named by device identifier in recall records posted in 2022.

Product	Company	Recall records	Class I
V. Mueller	Steris Corporation	45	—
V. Mueller	Carefusion 2200, Inc	17	—
ARROW	Teleflex Incorporated	12	9
MaxGuard	BD Switzerland Sàrl	9	—
Steri-Drape	3m Company	8	—
Palindrome	Mozarc Medical US LLC	8	8
Roadrunner	Cook Incorporated	5	—
Dover	Cardinal Health, Inc.	5	—
WatchCare	Hill-Rom, Inc.	4	4
Trackmaster	Full Vision, Inc.	4	—
LineSider	Integrity Implants Inc.	4	—
Centricity	Ge Healthcare	4	—

Companies with the most recall events

Company	Events	Records	Class I
Baxter Healthcare Corporation	13	31	11
GE Healthcare, LLC	12	27	3
Siemens Healthcare Diagnostics, Inc.	8	12	—
Siemens Medical Solutions USA, Inc	7	22	—
Philips North America Llc	7	15	—
MEDLINE INDUSTRIES, LP - Northfield	6	24	—
ROi CPS LLC	4	46	—
ARROW INTERNATIONAL Inc.	4	35	33
Covidien Llc	4	12	9
Microbiologics Inc	4	8	—
Boston Scientific Corporation	4	7	—
Fresenius Medical Care Holdings, Inc.	4	6	—

Companies that assemble kits or reprocess devices often appear high: when a component is recalled, every kit that contains it gets its own record.

Most-recalled device types

Device type (FDA product code)	Records	Class I
General surgery tray LRO	187	—
Electrosurgical, Cutting & Coagulation & Accessories GEI	53	—
System, Balloon, Intra-Aortic And Control DSP	34	31
Cardiovascular procedure kit OEZ	22	—
Wire, Guide, Catheter DQX	22	—
Catheter, Biliary, Diagnostic FGE	21	—
Interventional Fluoroscopic X-Ray System OWB	19	—
Orthopedic tray OJH	19	—
Drape, surgical, exempt PUI	18	—
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT	18	—
Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ	17	—
PWL PWL	15	—

Why devices were recalled

FDA root-cause category	Records	Share
Under Investigation by firm	238	20%
Nonconforming Material/Component	188	16%
Process control	140	12%
Device Design	106	9%
Packaging process control	81	7%
Environmental control	78	7%
Component change control	66	6%
Pending	40	3%
Error in labeling	30	3%
Storage	24	2%
Process change control	22	2%
Software design	19	2%

“Under Investigation by firm” means the company had not yet reported a root cause when the record was posted.

All Class I recalls in 2022 (143)

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pumpClass I
Z-0426-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pumpClass I
Z-0427-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pumpClass I
Z-0428-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pumpClass I
Z-0429-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pumpClass I
Z-0430-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pumpClass I
Z-0431-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pumpClass I
Z-0432-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump ↗Class I
Z-0433-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump ↗Class I
Z-0434-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump ↗Class I
Z-0435-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump ↗Class I
Z-0436-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump ↗Class I
Z-0437-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump ↗Class I
Z-0438-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump ↗Class I
Z-0439-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump ↗Class I
Z-0440-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump ↗Class I
Z-0441-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump ↗Class I
Z-0442-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump ↗Class I
Z-0443-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pumpClass I
Z-0444-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pumpClass I
Z-0445-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pumpClass I
Z-0446-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pumpClass I
Z-0447-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pumpClass I
Z-0448-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pumpClass I
Z-0449-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pumpClass I
Z-0450-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pumpClass I
Z-0451-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pumpClass I
Z-0452-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pumpClass I
Z-0453-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pumpClass I
Z-0454-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pumpClass I
Z-0455-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pumpClass I
Z-0456-2023 · ARROW INTERNATIONAL Inc. · posted Dec 15, 2022 · Open, Classified
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1Class I
Z-0351-2023 · ARROW INTERNATIONAL Inc. · posted Dec 10, 2022 · Terminated
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c)…Class I
Z-0352-2023 · ARROW INTERNATIONAL Inc. · posted Dec 10, 2022 · Terminated
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST ↗Class I
Z-0327-2023 · Remel Inc · posted Dec 8, 2022 · Terminated
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST ↗Class I
Z-0328-2023 · Remel Inc · posted Dec 8, 2022 · Terminated
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST ↗Class I
Z-0329-2023 · Remel Inc · posted Dec 8, 2022 · Terminated
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST ↗Class I
Z-0330-2023 · Remel Inc · posted Dec 8, 2022 · Terminated
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST ↗Class I
Z-0331-2023 · Remel Inc · posted Dec 8, 2022 · Terminated
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST ↗Class I
Z-0332-2023 · Remel Inc · posted Dec 8, 2022 · Terminated
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST ↗Class I
Z-0333-2023 · Remel Inc · posted Dec 8, 2022 · Terminated
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST ↗Class I
Z-0334-2023 · Remel Inc · posted Dec 8, 2022 · Terminated
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST ↗Class I
Z-0335-2023 · Remel Inc · posted Dec 8, 2022 · Terminated
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B ↗Class I
Z-0323-2023 · Dewei Medical Equipment CO Ltd · posted Dec 7, 2022 · Open, Classified
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit ↗Class I
Z-0336-2023 · Caire, Inc. · posted Dec 2, 2022 · Terminated
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit ↗Class I
Z-0337-2023 · Caire, Inc. · posted Dec 2, 2022 · Terminated
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit ↗Class I
Z-0338-2023 · Caire, Inc. · posted Dec 2, 2022 · Terminated
CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit ↗Class I
Z-0339-2023 · Caire, Inc. · posted Dec 2, 2022 · Terminated
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001 ↗Class I
Z-0236-2023 · Whele LLC DBA Perch · posted Nov 23, 2022 · Open, Classified
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002 ↗Class I
Z-0237-2023 · Whele LLC DBA Perch · posted Nov 23, 2022 · Open, Classified
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating ↗Class I
Z-0238-2023 · Whele LLC DBA Perch · posted Nov 23, 2022 · Open, Classified
18239: ASM Omnipod Dash PDM, insulin delivery system.Class I
Z-0154-2023 · Insulet Corporation · posted Nov 15, 2022 · Terminated
Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers:…Class I
Z-0141-2023 · Baxter Healthcare Corporation · posted Oct 31, 2022 · Open, Classified
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part…Class I
Z-0142-2023 · Baxter Healthcare Corporation · posted Oct 31, 2022 · Open, Classified
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part…Class I
Z-0143-2023 · Baxter Healthcare Corporation · posted Oct 31, 2022 · Open, Classified
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part…Class I
Z-0144-2023 · Baxter Healthcare Corporation · posted Oct 31, 2022 · Open, Classified
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product…Class I
Z-0145-2023 · Baxter Healthcare Corporation · posted Oct 31, 2022 · Open, Classified
Iso-Gard Filter S, REF : a) 19211, OUS onlyClass I
Z-0072-2023 · Teleflex LLC · posted Oct 14, 2022 · Open, Classified
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS onlyClass I
Z-0073-2023 · Teleflex LLC · posted Oct 14, 2022 · Open, Classified
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS onlyClass I
Z-0074-2023 · Teleflex LLC · posted Oct 14, 2022 · Open, Classified
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS onlyClass I
Z-0075-2023 · Teleflex LLC · posted Oct 14, 2022 · Open, Classified
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS onlyClass I
Z-0076-2023 · Teleflex LLC · posted Oct 14, 2022 · Open, Classified
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal…Class I
Z-0077-2023 · Teleflex LLC · posted Oct 14, 2022 · Open, Classified
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 ↗Class I
Z-0001-2023 · Jiangsu Well Biotech Co.,Ltd. · posted Oct 8, 2022 · Open, Classified
Ivenix Infusion System (IIS), LVP SoftwareClass I
Z-0002-2023 · Fresenius Kabi USA, LLC · posted Oct 6, 2022 · Terminated
Philips Respironics Amara View Minimal Contact Full-Face Mask ↗Class I
Z-1780-2022 · Philips Respironics, Inc. · posted Sep 30, 2022 · Open, Classified
Philips Respironics DreamWear Full Face Mask ↗Class I
Z-1781-2022 · Philips Respironics, Inc. · posted Sep 30, 2022 · Open, Classified
DreamWisp Nasal Mask with Over the Nose Cushion ↗Class I
Z-1782-2022 · Philips Respironics, Inc. · posted Sep 30, 2022 · Open, Classified
Wisp and Wisp Youth Nasal Mask ↗Class I
Z-1783-2022 · Philips Respironics, Inc. · posted Sep 30, 2022 · Open, Classified
Therapy Mask 3100 NC/SP ↗Class I
Z-1784-2022 · Philips Respironics, Inc. · posted Sep 30, 2022 · Open, Classified
TANDEM LIFE LivaNova LIFESPARC ControllerClass I
Z-1763-2022 · Cardiac Assist, Inc · posted Sep 23, 2022 · Terminated
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.Class I
Z-1653-2022 · Baxter Healthcare Corporation · posted Sep 14, 2022 · Terminated
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea…Class I
Z-1654-2022 · Philips Respironics, Inc. · posted Sep 9, 2022 · Open, Classified
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea…Class I
Z-1655-2022 · Philips Respironics, Inc. · posted Sep 9, 2022 · Open, Classified
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep…Class I
Z-1656-2022 · Philips Respironics, Inc. · posted Sep 9, 2022 · Open, Classified
Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep…Class I
Z-1657-2022 · Philips Respironics, Inc. · posted Sep 9, 2022 · Open, Classified
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with…Class I
Z-1658-2022 · Philips Respironics, Inc. · posted Sep 9, 2022 · Open, Classified
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for… ↗Class I
Z-1659-2022 · Philips Respironics, Inc. · posted Sep 9, 2022 · Open, Classified
NIM CONTACT EMG Endotracheal Tube, Part Numbers:Class I
Z-1519-2022 · Medtronic Xomed, Inc. · posted Sep 1, 2022 · Open, Classified
NIM EMG Endotracheal Tube, Part Numbers:Class I
Z-1520-2022 · Medtronic Xomed, Inc. · posted Sep 1, 2022 · Open, Classified
NIM EMG Endotracheal Tube, Part Numbers: ↗Class I
Z-1521-2022 · Medtronic Xomed, Inc. · posted Sep 1, 2022 · Open, Classified
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.Class I
Z-1522-2022 · Intera Oncology, Inc. · posted Aug 22, 2022 · Terminated
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.Class I
Z-1561-2022 · Synapse Biomedical Inc · posted Aug 22, 2022 · Terminated
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DEClass I
Z-1512-2022 · Heartware, Inc. · posted Aug 18, 2022 · Open, Classified
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4Class I
Z-1485-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Aug 9, 2022 · Open, Classified
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF…Class I
Z-1486-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Aug 9, 2022 · Open, Classified
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4Class I
Z-1487-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Aug 9, 2022 · Open, Classified
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D,…Class I
Z-1488-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Aug 9, 2022 · Open, Classified
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4Class I
Z-1489-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Aug 9, 2022 · Open, Classified
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D,…Class I
Z-1490-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Aug 9, 2022 · Open, Classified
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168…Class I
Z-1376-2022 · Baxter Healthcare Corporation · posted Jul 22, 2022 · Terminated
CereLink ICP Monitor ↗Class I
Z-1395-2022 · Integra LifeSciences Corp. · posted Jul 22, 2022 · Open, Classified
Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga,Class I
Z-1397-2022 · Bard Access Systems, Inc. · posted Jul 22, 2022 · Open, Classified
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000Class I
Z-1389-2022 · GE Healthcare, LLC · posted Jul 19, 2022 · Terminated
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic…Class I
Z-1312-2022 · Covidien Llc · posted Jul 7, 2022 · Open, Classified
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic…Class I
Z-1313-2022 · Covidien Llc · posted Jul 7, 2022 · Open, Classified
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic…Class I
Z-1314-2022 · Covidien Llc · posted Jul 7, 2022 · Open, Classified
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis,…Class I
Z-1315-2022 · Covidien Llc · posted Jul 7, 2022 · Open, Classified
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis,…Class I
Z-1316-2022 · Covidien Llc · posted Jul 7, 2022 · Open, Classified
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and…Class I
Z-1317-2022 · Covidien Llc · posted Jul 7, 2022 · Open, Classified
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and…Class I
Z-1318-2022 · Covidien Llc · posted Jul 7, 2022 · Open, Classified
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and…Class I
Z-1319-2022 · Covidien Llc · posted Jul 7, 2022 · Open, Classified
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis,…Class I
Z-1320-2022 · Covidien Llc · posted Jul 7, 2022 · Open, Classified
Clean Catch Urine Kit NS 178489, AHMU58AClass I
Z-1276-2022 · American Contract Systems, Inc. · posted Jul 1, 2022 · Open, Classified
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18AClass I
Z-1277-2022 · American Contract Systems, Inc. · posted Jul 1, 2022 · Open, Classified
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of…Class I
Z-1278-2022 · Getinge Usa Sales Inc · posted Jun 23, 2022 · Terminated
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of…Class I
Z-1279-2022 · Getinge Usa Sales Inc · posted Jun 23, 2022 · Terminated
Back up batteries in Ventilators labeled as the following:Class I
Z-1226-2022 · GE Healthcare, LLC · posted Jun 6, 2022 · Open, Classified
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and…Class I
Z-1227-2022 · GE Healthcare, LLC · posted Jun 6, 2022 · Open, Classified
In-Line ventilator adaptorClass I
Z-1138-2022 · Baxter Healthcare Corporation · posted May 30, 2022 · Terminated
In-Line ventilator adaptorClass I
Z-1139-2022 · Baxter Healthcare Corporation · posted May 30, 2022 · Terminated
Sara Plus Active Floor Lift ↗Class I
Z-1098-2022 · ARJOHUNTLEIGH POLSKA Sp. z.o.o. · posted May 21, 2022 · Terminated
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EOClass I
Z-1095-2022 · Abbott Vascular · posted May 19, 2022 · Open, Classified
Atrium Advanta V12 Covered Stent System (OUS only). ↗Class I
Z-1076-2022 · Atrium Medical Corporation · posted May 18, 2022 · Open, Classified
iCast Covered Stent SystemClass I
Z-1077-2022 · Atrium Medical Corporation · posted May 18, 2022 · Open, Classified
Avanos Cortrak 2 Enteral Access System (EAS)Class I
Z-1032-2022 · Avanos Medical, Inc. · posted May 13, 2022 · Terminated
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 ↗Class I
Z-0953-2022 · Celltrion USA Inc · posted Apr 27, 2022 · Terminated
Puritan Bennett 980 Series VentilatorClass I
Z-0966-2022 · Medtronic formerly Covidien · posted Apr 25, 2022 · Open, Classified
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618,…Class I
Z-0907-2022 · Respironics California, LLC · posted Apr 18, 2022 · Open, Classified
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276) ↗Class I
Z-0908-2022 · Respironics California, LLC · posted Apr 18, 2022 · Open, Classified
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United… ↗Class I
Z-0909-2022 · Respironics California, LLC · posted Apr 18, 2022 · Open, Classified
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation…Class I
Z-0927-2022 · Medtronic Inc · posted Apr 18, 2022 · Open, Classified
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in…Class I
Z-0694-2022 · ev3 Inc. · posted Mar 7, 2022 · Terminated
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in…Class I
Z-0695-2022 · ev3 Inc. · posted Mar 7, 2022 · Terminated
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 ↗Class I
Z-0659-2022 · Celltrion USA Inc · posted Mar 2, 2022 · Terminated
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 ↗Class I
Z-0680-2022 · Celltrion USA Inc · posted Mar 2, 2022 · Terminated
Philips Respironics V60 Ventilator Part Number 1053617Class I
Z-0662-2022 · Respironics California, LLC · posted Feb 25, 2022 · Open, Classified
Philips Respironics V60 Plus Ventilator Part Number 1138747 ↗Class I
Z-0663-2022 · Respironics California, LLC · posted Feb 25, 2022 · Open, Classified
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130.Class I
Z-0622-2022 · Vyaire Medical · posted Feb 16, 2022 · Terminated
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components:…Class I
Z-0623-2022 · Teleflex Medical Inc · posted Feb 15, 2022 · Terminated
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components:…Class I
Z-0624-2022 · Teleflex Medical Inc · posted Feb 15, 2022 · Terminated
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-CClass I
Z-0625-2022 · Teleflex Medical Inc · posted Feb 15, 2022 · Terminated
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components:…Class I
Z-0626-2022 · Teleflex Medical Inc · posted Feb 15, 2022 · Terminated
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-TClass I
Z-0627-2022 · Teleflex Medical Inc · posted Feb 15, 2022 · Terminated
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components:…Class I
Z-0628-2022 · Teleflex Medical Inc · posted Feb 15, 2022 · Terminated
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit)Class I
Z-0629-2022 · Teleflex Medical Inc · posted Feb 15, 2022 · Terminated
E25Bio COVID-19 Direct Antigen Rapid Test ↗Class I
Z-0564-2022 · E25Bio, Inc. · posted Feb 9, 2022 · Terminated
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass.Class I
Z-0550-2022 · Abiomed, Inc. · posted Feb 3, 2022 · Terminated
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.Class I
Z-0529-2022 · Baxter Healthcare Corporation · posted Jan 29, 2022 · Open, Classified
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.Class I
Z-0530-2022 · Baxter Healthcare Corporation · posted Jan 29, 2022 · Open, Classified
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea)Class I
Z-0493-2022 · Philips Respironics, Inc. · posted Jan 22, 2022 · Open, Classified
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257Class I
Z-0494-2022 · Philips Respironics, Inc. · posted Jan 22, 2022 · Open, Classified
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm)…Class I
Z-0450-2022 · ev3 Inc. · posted Jan 19, 2022 · Terminated
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm)…Class I
Z-0451-2022 · ev3 Inc. · posted Jan 19, 2022 · Terminated

About this data

Unit: a recall record is one product in an FDA recall (one recall number, e.g. Z-1234-2022). A recall event can include several products.
Date: records are counted by the date the FDA posted them, not the date the company started the recall.
Class: from FDA enforcement reports. Records without a class have not been classified yet.
Limits: recall counts do not measure how safe a device or company is. Companies with many products, kits or proactive quality systems can have more recalls. How recalls work.
Sources: FDA Medical Device Recalls database and FDA enforcement reports, via openFDA. Methodology.

Citing this report: “Device Safety Index, Medical Device Recalls in 2022, analysis of FDA recall data,” with a link to this page. Questions or corrections: contact us.