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

16176–16200 of 40287

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
HighFDA (Devices)·Z-0229-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal.
Product
78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0266-2021·2020-10-28
ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent the spike from sealing properly.
Product
8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)250201(30)50(10)4717491. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0275-2021·2020-10-28
ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.
Product
226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619061231(17)250201(30)50(10)4734990. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0147-2021·2020-10-28
Smith & Nephew Recalls Raptormite Suture Anchors Due to Seal Defects
Smith & Nephew is recalling Raptormite suture anchors because improper packaging seals may breach the sterile barrier.
Product
RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0143-2021·2020-10-28
Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors
Smith & Nephew is recalling Ultra Fast-Fix AB Assembly suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0132-2021·2020-10-28
Maquet Yuno Mobile Operating Table Recalled for Electric Shock Risk
Maquet is recalling Yuno Mobile Operating Tables because a plastic socket may pull out, exposing electronic parts and creating an electric shock hazard.
Product
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0198-2021·2020-10-28
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
107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(17)250101(30)50(10)4572911. The Intravascular Administration Set is a single use, sterile…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0247-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular 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
7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0223-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.
Product
26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0238-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.
Product
11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709069524(17)250201(30)50(10)4711196. The Intravascular Administration Set is a single use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0212-2021·2020-10-28
ICU Medical NanoClave Stopcock Recalled for Potential Manufacturing Defect
ICU Medical is recalling NanoClave Stopcocks due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
Product
NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0253-2021·2020-10-28
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
60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors
Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
Category
Medical Device
Distribution
Distributed nationwide

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16176–16200 of 40287