Browse Device Recalls
3,191 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,191 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 3,191 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 9, 2020 | TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 7... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product N... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product N... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991 | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Nu... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702 | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product N... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Nu... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Numbe... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 721... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Numbe... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 7220... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 8, 2020 | MediCult Vitrification Cooling Media, Model Number 12284001F | There is a discrepancy between the printing on the Product Tyvek label of the individual componen... | Class II | CooperSurgical, Inc. |
| Jun 30, 2020 | Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage:... | Potential for sterile packaging to be compromised¿ | Class II | TELEFLEX MEDICAL INC |
| Jun 30, 2020 | Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product ... | Potential for sterile packaging to be compromised¿ | Class II | TELEFLEX MEDICAL INC |
| Jun 24, 2020 | Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S -... | Screws provided in packaging are 5mm shorter than intended | Class II | Arthrex, Inc. |
| Jun 24, 2020 | SUTUREFIX ULTRA Suture, Product number 72203855 | A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL d... | Class II | Smith & Nephew, Inc. |
| Jun 15, 2020 | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell C... | Convenience kit mislabeled with the incorrect catheter effective length on the device label and t... | Class III | Access Scientific LLC |
| May 4, 2020 | Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline... | There is a potential for the product to exhibit holes in the packaging, which impacts package int... | Class II | Resource Optimization & Innovation LLC |
| May 4, 2020 | Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Fl... | There is a potential for the product to exhibit holes in the packaging, which impacts package int... | Class II | Resource Optimization & Innovation LLC |
| Apr 24, 2020 | Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for ... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for In... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for In... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Inser... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Ins... | The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... | Class II | LivaNova USA Inc. |
| Apr 24, 2020 | Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-0... | Packaging of infant child reduced energy electrodes was not properly sealed. | Class II | Physio-Control, 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.