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Browse Device Recalls

812 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 812 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 812 FDA device recalls in PR.

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DateProductReasonClassFirm
Jan 11, 2016 Product 47 consists of all product under product code: LPH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 40 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 71 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 13 consists of all product under product code HWC , and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 22 consists of all product under product code: JDI and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 20 consists of all prod oct under poduct code: KTT and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 66 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 70 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 63 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 53 consists of all product under: product code: JWH and same usage... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 60 consists of all product under product code: HSB and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 30 consists of all product under product code: KTT and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 69 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 46 consists of all product under product code: HWC and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 16 consists of all product under poduct code: KWY and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 4 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 43 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 42 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 56 consists of all product under product code: HWC and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 15 consists of all product code JDI , and same usage: Item no: 80... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 3 consists of all products under product code JDI, and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 8 consists of all products under product code HWC, and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 7 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 27 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 37 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 64 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 1 consists of all product under , product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 54 consists of all product under product code: JWH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 67 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 35 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 19 consists of all product code: JDI and same usage: Item no: 7653... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 62 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 14 consists of all product under product code HSB , and same usage:... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 65 consists of all product under product code: KTT and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 10consists of all product under product code HWC, and same usage: It... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 59 consists of all product under product code: JWH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 34 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 45 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 17 consists of all product under product code: LPH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 36 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 51 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 28 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 5 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 18 consists of all product under product code: HWC and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 52 consists of product code: HWC and same usage: Item no: 52500453... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 29 consists of all product under product code: LPHand same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 31 consists of all product under product code: KTT and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 12 consists of all product under product code JDI , and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 48 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 25 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.

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.