Browse Device Recalls
2,549 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,549 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,549 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 24, 2020 | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G5... | There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... | Class I | Cook Inc. |
| Nov 24, 2020 | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G5... | There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... | Class I | Cook Inc. |
| Nov 24, 2020 | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5... | There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... | Class I | Cook Inc. |
| Nov 24, 2020 | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G5... | There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... | Class I | Cook Inc. |
| Nov 24, 2020 | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G5... | There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... | Class I | Cook Inc. |
| Nov 24, 2020 | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5... | There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... | Class I | Cook Inc. |
| Nov 23, 2020 | cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric... | During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically ... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2020 | Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin c... | Device has the potential for fracture during use. | Class II | Zimmer Biomet, Inc. |
| Nov 17, 2020 | Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbos... | Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU)... | Class II | Zimmer Biomet, Inc. |
| Nov 6, 2020 | Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usa... | Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 22, 2020 | Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved... | Affected product was dropped during manufacturing, which may result in a bent wire guide and/or t... | Class I | Cook Inc. |
| Oct 9, 2020 | cobas infinity central lab/cobas infinity core license-The cobas infinity IT ... | Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expira... | Class II | Roche Diagnostics Operations, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, ... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, ... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, S... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, S... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, S... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.