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Browse Device Recalls

21 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 21 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 21 FDA device recalls.

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DateProductReasonClassFirm
Oct 13, 2023 Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revisi... Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity... Class II Corin Ltd
Oct 13, 2023 Unity Total Knee System, Model Number 112.001.34. Primary and revision t... Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity... Class II Corin Ltd
Nov 8, 2022 Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. Class II Corin Ltd
Nov 8, 2022 Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. Class II Corin Ltd
Oct 31, 2022 Unity Total Knee System. Used for knee prosthesis in total knee replacement The internal packaging system for devices may have damage to the blisters potentially damaging th... Class II Corin Ltd
Jul 22, 2022 Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEM... One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix ... Class II Corin Ltd
Jul 12, 2022 TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Ce... Some of the devices did not pass fatigue testing. Class II Corin Ltd
Jul 28, 2021 Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 3... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 3... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, RE... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augm... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, R... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWP... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
May 6, 2021 Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS,... Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem... Class II Corin Ltd
May 6, 2021 Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hi... Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem... Class II Corin Ltd
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Aceta... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd
Jan 25, 2021 Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acet... The size indicated on the labeling on the outer packaging, on the inner packaging, and on the pat... Class II Corin Ltd

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.