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Browse Device Recalls

317 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 317 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 317 FDA device recalls.

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DateProductReasonClassFirm
Dec 1, 2023 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DURATION PLASTIC PATELLA-DURACON Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replace... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part N... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement P... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Numb... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replac... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DUR PCA MTK REV INS RT Intended for knee replacement Product... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Pr... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DUR PCA MTK REV INS LFT Intended for knee replacement Product N... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacem... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DUR PCA MTK REV INS LFT Intended for knee replacement Product Number:... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 7... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replaceme... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacem... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Prod... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
Dec 1, 2023 Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement ... Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... Class II Howmedica Osteonics Corp.
May 3, 2023 Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is... Class II Howmedica Osteonics Corp.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Apr 13, 2023 TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement... Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM... Class II Howmedica Osteonics Corp.
Mar 10, 2023 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intende... Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produ... Class II Howmedica Osteonics Corp.
Mar 10, 2023 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intende... Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain produc... Class II Howmedica Osteonics Corp.
Nov 7, 2022 Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prosth... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Nov 7, 2022 Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of pro... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Oct 21, 2022 Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog N... Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had o... Class II Howmedica Osteonics Corp.
Aug 24, 2022 Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis co... A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ... Class II Howmedica Osteonics Corp.

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.