PolysorbRecalls & reported problems across all models
Covidien LP · 291 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Polysorb model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4,564
- Deaths reported
- 0
- Injuries reported
- 648
- Recalls
- 2
We found 291 models of Polysorb by Covidien LP in the FDA's device registry (GUDID). Together they are named in 4,564 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2016 and Sep 30, 2026 — classified as 648 injuries, 3,916 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2,190 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Polysorb recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 15, 2026Open, Classified
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Z-2281-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Jun 15, 2018Terminated
Potential proplylene glycol contamination
Z-2601-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported Polysorb problems
Device problems
- Detachment of Device or Device Component2,190
- Break1,946
- Patient-Device Incompatibility290
- Adverse Event Without Identified Device or Use Problem274
- Unraveled Material131
- Manufacturing, Packaging or Shipping Problem91
- Product Quality Problem84
- Detachment Of Device Component70
Patient problems
- No Clinical Signs, Symptoms or Conditions2,627
- Insufficient Information650
- No Consequences Or Impact To Patient329
- No Known Impact Or Consequence To Patient317
- No Code Available209
- Wound Dehiscence164
- Foreign Body In Patient111
- Unintended Radiation Exposure109
Polysorb models
291 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Polysorb CL-915SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Polysorb CL-923SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID321 reports
- Polysorb CL-813SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID274 reports
- Polysorb SL-712SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID185 reports
- Polysorb SL-5687SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID155 reports
- Polysorb CL-914SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID138 reports
- Polysorb GL-885SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID136 reports
- Polysorb SL-691SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID116 reports
- Polysorb 170053Endoscopic tissue approximation device1 recall63 reports
- Polysorb CL-925SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID98 reports
- Polysorb GL-182SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID96 reports
- Polysorb GL-223SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID82 reports
- Polysorb GLJ-50-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID70 reports
- Polysorb CL-812SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID69 reports
- Polysorb GL-122SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID66 reports
- Polysorb CL-924SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID65 reports
- Polysorb 170052Endoscopic tissue approximation device57 reports
- Polysorb CL-802SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID55 reports
- Polysorb CL-955SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall5 reports
- Polysorb CL-803SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID54 reports
- Polysorb 170071Endoscopic tissue approximation device1 recall2 reports
- Polysorb UL-877SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID50 reports
- Polysorb CL-894SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID48 reports
- Polysorb GL-123SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID48 reports
- Polysorb SL-693SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID48 reports
- Polysorb CL-944SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID46 reports
- Polysorb GL-181SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID44 reports
- Polysorb UL-202SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID42 reports
- Polysorb UL-878SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID41 reports
- Polysorb CL-922SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID40 reports
- Polysorb UL-203SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID40 reports
- Polysorb CL-977SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID37 reports
- Polysorb GL-34-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID34 reports
- Polysorb 170056Endoscopic tissue approximation device34 reports
- Polysorb GL-33-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID30 reports
- Polysorb L-1742KSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID30 reports
- Polysorb GLS-322SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID29 reports
- Polysorb SL-636SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID29 reports
- Polysorb SL-5690SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID28 reports
- Polysorb CL-845SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID27 reports
- Polysorb CL-936SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID27 reports
- Polysorb GL-323SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID27 reports
- Polysorb SL-694SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID26 reports
- Polysorb GL-69-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID25 reports
- Polysorb CL-905SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID22 reports
- Polysorb UL-102SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID21 reports
- Polysorb CL-932SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID20 reports
- Polysorb GLJ-51-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID20 reports
- Polysorb SL-5627SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID20 reports
- Polysorb SL-822SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID20 reports
- Polysorb GLJ-53-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID19 reports
- Polysorb XX-5202JSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID19 reports
- Polysorb CL-843SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Polysorb CLT-957SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Polysorb SL-5637SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- Polysorb CL-516SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID17 reports
- Polysorb GL-124SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID17 reports
- Polysorb SL-692SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID16 reports
- Polysorb CL-945SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- Polysorb CLT-21-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- Polysorb GL-322SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- Polysorb L-2748KSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- Polysorb CL-10-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- Polysorb CL-5-MSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- Polysorb CL-823SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- Polysorb CLT-250-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- Polysorb GL-63-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- Polysorb UL-879SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- Polysorb GL-46-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- Polysorb GLS-323SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- Polysorb SL-5687GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- Polysorb CL-20-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- Polysorb CL-830SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- Polysorb CL-884SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- Polysorb CL-964SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- Polysorb GL-62-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- Polysorb L-1796KSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- Polysorb CL-86-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID10 reports
- Polysorb UL-214SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID10 reports
- Polysorb 170051Endoscopic tissue approximation device10 reports
- Polysorb CL-869SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Polysorb CL-9-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Polysorb GL-129SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Polysorb GL-224SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Polysorb GL-303SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Polysorb GLS-122SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- Polysorb CL-811SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Polysorb CL-943SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Polysorb SL-5691GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Polysorb SL-632SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- Polysorb 170057Endoscopic tissue approximation device8 reports
- Polysorb CL-239SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Polysorb CL-544SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Polysorb CL-829SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Polysorb CL-842SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Polysorb CL-892SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Polysorb CL-918SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Polysorb GL-192SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Polysorb UL-204SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- Polysorb CL-13-MGSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID6 reports
Recent Polysorb adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951891 ↗MalfunctionSep 30, 2026Break
It was reported that during a right thyroid lobectomy and isthmusectomy plus right level VI lymph node dissection, while on skin closure, the suture suddenly broke and suturing could not continue. To avoid delaying the procedure, the circulating nurse checked the expiration date and provided a new suture. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941722 ↗MalfunctionSep 29, 2026Break
Patient problems: Insufficient Information
MAUDE report 50937404 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934169 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924118 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883927 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883804 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883747 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883705 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883647 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883566 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883402 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883346 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883261 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882944 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
- Puritan Bennett119 models · 3,169 reports · 18 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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