Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

12851–12875 of 27471

HighFDA (Devices)·Z-0209-2021·2020-10-28
ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of Smallbore Bifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: ¿(01)10887709090238(17)250101(30)50(10)4572966; (01)10887709090238(17)250101(30)50(10)4557530. The Intravascular Administration Set is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0115-2021·2020-10-28
Siemens Recalls HER-2/neu Assay Kits Due to Inaccurate Results
Siemens Healthcare Diagnostics is recalling specific HER-2/neu assay kits and calibrators because the Upper Limit of Normal was not achieved, potentially causing false positive or negative results.
Product
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0270-2021·2020-10-28
ICU Medical Recalls NanoClave Administration Sets Due to Manufacturing Defect
ICU Medical is recalling specific lots of NanoClave administration sets due to a potential manufacturing defect on the internal surface that may inhibit a proper seal.
Product
165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619062761(17)241201(30)50(10)4553703. Administration sets and their accessories are single use, pre-sterilized devices that provide access for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0199-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a manufacturing defect that may prevent a proper seal.
Product
9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)4558471. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0167-2021·2020-10-28
Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Defects
Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0136-2021·2020-10-28
Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX 5.0mm suture anchors because improper packaging seals may breach the sterile barrier.
Product
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0142-2021·2020-10-28
Smith & Nephew Recalls TWINFIX AB 5.0 Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX AB 5.0 Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0145-2021·2020-10-28
Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors
Smith & Nephew is recalling Ultra Fast-Fix AB Assembly absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0175-2021·2020-10-28
Smith & Nephew Recalls Microraptor RegenSorb Suture Anchors for Seal Issues
Smith & Nephew is recalling Microraptor RegenSorb Suture Anchors because improper or incomplete pouch seals may breach the sterile barrier.
Product
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0125-2021·2020-10-28
BD Nexiva Closed IV Catheter System Recalled for Dull Needles
Becton Dickinson is recalling 12,020 units of BD Nexiva Closed IV Catheter Systems due to dull needles that may delay medical treatment.
Product
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0161-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX ULTRA PLLA HA 6.5MM suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0224-2021·2020-10-28
ICU Medical Recalls NanoClave Manifold Sets Due to Seal Defect
ICU Medical is recalling specific lots of 3-Port NanoClave Manifold sets due to a potential manufacturing defect that may inhibit a proper seal with the spike.
Product
3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50(10)4579939; (01)10887709087153(17)250101(30)50(10)4592179…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0188-2021·2020-10-28
ICU Medical Recalls Trifuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of Trifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709052816(17)241201(30)50(10)4537141 The Intravascular Administration…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0272-2021·2020-10-28
ICU Medical Recalls APPX NanoClave Manifold Sets Due to Seal Defect
ICU Medical is recalling specific lots of APPX 0.75ml NanoClave Manifold sets because a manufacturing defect may prevent a proper seal.
Product
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619083929(17)241201(30)50(10)4496182. Administration sets and their accessories are single use, pre-sterilized devices that provide access…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0181-2021·2020-10-28
Boston Scientific Recalls Opticross 35 Peripheral Imaging Catheters
Boston Scientific is recalling 41 Opticross 35 Peripheral Imaging Catheters because length markings may flake off during manipulation. No patient harm has been reported.
Product
Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a potential manufacturing defect that may inhibit a proper seal.
Product
9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0227-2021·2020-10-28
ICU Medical Recalls NanoClave Sets Due to Potential Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a potential manufacturing defect that may inhibit a proper seal.
Product
142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948;(01)10887709089393(17)250101(30)25(10)4603380; (01)10887709089393(17)250101(30)25(10)4711169…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0245-2021·2020-10-28
ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.
Product
126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)250201(30)25(10)4630752. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0133-2021·2020-10-28
Maquet Yuno II Mobile Operating Table Recalled for Electric Shock Risk
Maquet is recalling Yuno II Mobile Operating Tables because a plastic socket may pull out, exposing electronic parts and creating an electric shock hazard.
Product
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2021·2020-10-28
Encore Medical Recalls EMPOWR Acetabular Cups Due to Machining Defect
Encore Medical is recalling 12 EMPOWR Acetabular Cups due to a manufacturing defect that prevents proper seating. The affected cups were distributed nationwide in specific U.S. states.
Product
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0241-2021·2020-10-28
ICU Medical Recalls NanoClave Manifold Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave Manifold sets because a manufacturing defect may prevent a proper seal with the spike.
Product
6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)250101(30)50(10)4573963; (01)10887709087719(17)241201(30)50(10)4515215. The Intravascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0213-2021·2020-10-28
ICU Medical NanoClave Stopcock Manifold Recalled for Manufacturing Defect
ICU Medical is recalling specific lots of NanoClave Stopcock Manifolds due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
Product
2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)241201(30)50(10)4536673. The ICU Medical Clave Stopcock is a device used to administer or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0257-2021·2020-10-28
ICU Medical Recalls NanoClave Sets Due to Potential Manufacturing Defect
ICU Medical is recalling specific lots of NanoClave sets due to a potential manufacturing defect that may inhibit a proper seal with the NanoClave spike.
Product
98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709076119(17)250101(30)25(10)4584862. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0204-2021·2020-10-28
ICU Medical Recalls NanoClave High Pressure Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave high pressure extension sets because a manufacturing defect may prevent a proper seal.
Product
6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080390(17)250101(30)50(10)4572792. The high pressure extension set is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0169-2021·2020-10-28
Smith & Nephew Recalls Healicoil Suture Anchors Due to Packaging Seal Issues
Smith & Nephew is recalling Healicoil absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
Category
Medical Device
Distribution
Distributed nationwide

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